Bush FDA decision put patients in danger

Wednesday, 18 February 2009 16:15

The Food and Drug Administration put patients' lives at risk by halting enforcement of 30-year-old requirements that medical device makers meet federal laboratory standards prior to testing their products on humans, a watchdog group charges in a new report.

The rules at issue cover studies on an array of devices, including life-saving products such as defibrillators, pacemakers, coronary stents and heart valves.